Some people saw it coming. Others were blindsided by a pink slip. The recent wave of job cuts this week added more people to the growing ranks of the nation’s unemployed. A CNNMoney article today puts the week’s total to more than 100,000 so far. Read more »

Two new studies highlight the steps-some of them too risky-that patients are taking to protect their pockets from totally emptying.

One study from the Center for Studying Health System Change reports that one in seven children and working-age Americans went without a prescription drug in 2007 because of cost concerns. Read more »

Universal healthcare remains a hotly debated topic as the country prepares for a new executive administration. Already future Health and Human Services Secretary Tom Daschle has pointed to public access of generic medicines as an integral part of the solution, to the approval of the Generic Pharmaceutical Association. Today, the Biotechnology Industry Organization (BIO) released its “critical principles” toward universal healthcare, with an emphasis on innovation in therapies and diagnostics. Read more »

It’s official. The wires had been buzzing with rumors for several days, and today Pfizer (New York) announced that it would acquire Wyeth (Madison, NJ) for about $68 billion. The transaction will bolster Pfizer’s pipeline and improve its biopharmaceutical portfolio with the addition of Wyeth’s “Prevnar” pneumococcal vaccine and “Enbrel” arthritis treatment. The resulting company will be so diversified that it expects that no drug will account for more than 10% of its revenue in 2012, according to a Pfizer press release. Read more »

The ability of the US Food and Drug Administration to effectively regulate the safety of drugs, medical devices and food, continues to be an issue of debate. This week, the US Government Accountability Office (GAO) issued a report that named FDA among the federal government’s high-risk areas. GAO issues the list at the start of each Congress to help identify legislative priorities and issues. Read more »

Key results from a colon cancer study of Genentech’s Avastin (bevacizumab) could be available in April, according to a Securities and Exchange Commission filing. Genentech previously said results would be available mid-year. The drug is currently approved to treat breast and lung cancer, and it’s a first- and second-line treatment for metastatic colorectal cancer. Read more »

No doubt millions were moved by President Barack Obama’s inauguration speech yesterday. Having listened to and read it several times, it occurred to me that many of his messages apply directly to our industry. Read more »

The US Food and Drug Administration was buffeted by questions and criticism last year after the emergence of contaminated heparin. Lawmakers questioned whether the agency had investigated the problem thoroughly and been forthcoming about its findings. Several of FDA’s recent measures provide reassurance that it is attempting to protect American patients from contaminated drugs produced abroad. Read more »

Last month, the International AIDS Vaccine Initiative (IAVI) and the Rockefeller Foundation announced a challenge to HIV/AIDS scientists: design an AIDS-fighting protein to win $150,000. The winning protein design and sample will advance HIV vaccine development, and the winning researchers could receive a bonus of up to $1 million and/or the chance to pursue their research further with help from IAVI. Read more »

I participated in an ISPE webinar yesterday with FDA’s Grace McNally regarding the agency’s recently released draft guidance, Process Validation: General Principles and Practices. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation. Read more »